IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)— 510(k) K221348

Substantially Equivalent

Philips Medizin Systeme Böblingen GmbH

FDA 510(k) clearance K221348 for IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470), Substantially Equivalent on 2023-02-03. Applicant: Philips Medizin Systeme Böblingen GmbH.

Clearance details

Applicant: Philips Medizin Systeme Böblingen GmbH
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2022-05-09
Decision date: 2023-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boeblingen, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.